MAUDE Adverse Event Report: AMO UPPSALA AB HEALON DUET PRO; AID, SURGICAL, VISCOELASTIC

Model Number 10-2400-16

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

It is reported that after injection of the healon5 pro a small particle of plastic was observed in the patient's left eye.Issue was notified during implantation or application.It was removed and there was no delay in procedure reported.No medical or surgical interventions reported.It was noted that patient's daily activities were not significantly affected.Patient is fully recovered post-op.No other information was provided.

Manufacturer Narrative

Unknown, information not provided.If implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  phone number: +011(514)7810483.The healon 5 pro is not returned for evaluation.Therefore; a failure analysis of the complaint device cannot be completed.A review of the device lot history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON DUET PRO
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala, uppsala län 754 5 0; SW 754 50
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14123818
• MDR Text Key: 298781522
• Report Number: 3012236936-2022-01002
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651425
• UDI-Public: (01)05050474651425(17)220930(10)UJ31037
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 10-2400-16
• Device Catalogue Number: 10240016
• Device Lot Number: UJ31037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male